EryDex for Ataxia Telangiectasia
(OLE_NEAT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an international, multi-center, prospective, open-label, non-comparative study to provide EryDex treatment to ataxia telangiectasia (A-T) patients who complete the IEDAT-04-2022 trial on the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot participate if you require treatment with a systemic corticosteroid (a type of medication that reduces inflammation).
Is EryDex (dexamethasone) generally safe for humans?
Dexamethasone, used in various forms like the Ozurdex implant, is generally considered safe with few adverse events reported in studies for eye conditions such as macular edema and uveitis. It has been evaluated for safety in different delivery systems, including implants and eyedrops, with a focus on minimizing inflammation and ensuring patient tolerance.12345
How is the drug Dexamethasone sodium phosphate unique for treating Ataxia Telangiectasia?
What evidence supports the effectiveness of the drug Dexamethasone sodium phosphate for treating Ataxia Telangiectasia?
Dexamethasone, used in various forms like implants, has been shown to be effective in treating conditions like diabetic macular edema and non-infectious uveitis by reducing inflammation and swelling. While this is not directly related to Ataxia Telangiectasia, it suggests that Dexamethasone can be effective in managing inflammation-related symptoms.23111213
Who Is on the Research Team?
Dirk Thye, MD
Principal Investigator
Quince Therapeutics S.p.A.
Are You a Good Fit for This Trial?
This trial is for patients with Ataxia Telangiectasia who have completed the IEDAT-04-2022 study. It's an international study, but specific eligibility criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Extension
Participants receive EryDex treatment for ataxia telangiectasia following completion of the NEAT trial
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone sodium phosphate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Quince Therapeutics S.p.A.
Lead Sponsor
Biotrial
Industry Sponsor